Controversy Over Novo Nordisk's Wegovy as Phase 3 Trials Show Reduced Liver Fibrosis

Novo Nordisk has recently shared the primary outcomes from Part 1 of its significant Phase 3 clinical trial, ESSENCE. This trial evaluates the effectiveness of Wegovy (semaglutide), a weight-loss therapy, in reducing liver fibrosis symptoms in patients with metabolic-associated steatohepatitis (MASH). The findings reveal that Wegovy notably diminishes liver fibrosis symptoms and promotes the resolution of steatohepatitis when compared to a placebo.

The ESSENCE trial, a crucial Phase 3 study, aims to assess the efficacy and safety of administering 2.4 mg of semaglutide subcutaneously on a weekly basis against a placebo in adults suffering from MASH coupled with moderate to severe liver fibrosis (stage 2 or 3). The trial results underscore the substantial impact of Wegovy on liver fibrosis improvement and steatohepatitis regression without any exacerbation. By week 72, 37.0% of patients treated with Wegovy exhibited improved liver fibrosis without worsening of steatohepatitis, in stark contrast to the 22.5% observed in the placebo group. Furthermore, a striking 62.9% of patients in the Wegovy cohort saw their steatohepatitis resolve without any worsening of liver fibrosis, compared to 34.1% of patients receiving the placebo.

Given these promising results, Novo Nordisk is planning to file for regulatory approval for Wegovy to treat MASH with regulatory bodies in the United States and the European Union in the first half of 2025. Detailed findings from the ESSENCE trial are anticipated to be shared at an upcoming scientific conference.

The continuing Part 2 of the ESSENCE trial will provide further insights, with the final results expected by 2029. The ongoing research and data collection will undoubtedly shape the future application of Wegovy in treating MASH, potentially offering a new therapeutic avenue for patients afflicted with this condition.

Overall, the findings from the ESSENCE trial bolster the potential of Wegovy as a beneficial treatment for MASH, showcasing its ability to significantly improve liver fibrosis and resolve steatohepatitis without adverse progression. This advancement could mark a significant step forward in addressing the needs of patients with MASH and related metabolic dysfunctions.